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Contact Information:

Dr Study Team
+44 121 415 9125
curly@trials.bham.ac.uk


Dr Stuart Hartshorn
+44 121 3339527
stuart.hartshorn@nhs.net


More information about this study, what is involved and how to take part can be found on the study website.

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Be Part of Research - Trial Details - Determining the optimal duration of oral antibiotic cefalexin treatment for infants and young children with a clinical diagnosis of febrile urinary tract infection.
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Determining the optimal duration of oral antibiotic cefalexin treatment for infants and young children with a clinical diagnosis of febrile urinary tract infection.

Recruiting

Open to: All Genders

Age: Child

Birmingham London Preston Leicester London Belfast Bristol Sheffield Liverpool Dublin

Medical Conditions

Urinary tract infections

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


Urine infections are very common in children. They can cause fever, abdominal pain and vomiting, and are usually treated with antibiotics. In adults, just a few days of antibiotics is usually enough to stop the infection. However, it is unclear if this is the same for children. Shorter treatment with antibiotics has benefits over longer treatments, including less side effects (e.g. diarrhoea, vomiting and rash) and a lower chance of developing bugs resistant to antibiotics (i.e. bacteria that antibiotics can’t kill).

The CURLY trial aims to improve the treatment of children who have urine infections by finding out the shortest course of antibiotics which is effective to successfully cure the infection. The antibiotic used will be cefalexin, which is the most commonly used antibiotic used to treat this type of infection.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

01 Oct 2023 31 Aug 2025

The study will be conducted in at least 8 UK emergency departments and will last for a total of 30 months. Around 705 children will take part. The amount of antibiotics that children get will be either a 3, 5, 6, 8, or 10 day course. The amount of antibiotics that each child receives will be chosen fairly, using a study process called ‘randomisation’, where each child has an equal chance of getting one of the different courses.

After being discharged home from the emergency department, parents will use a smartphone or computer app to log antibiotic doses and report their child’s symptoms. A follow-up appointment after 16-days will assess the child’s symptoms and check that the infection has cleared from the urine. A further urine sample will be tested after 30 days to check that the infection hasn’t come back. More antibiotics will be prescribed if the treatment is not working well.


Children (aged between 3 months and 11 years) with a urine infection.

You can take part if:



You may not be able to take part if:


1. Known congenital anomalies of the kidney and urinary tract (CAKUT), reflux nephropathy or indwelling catheter. 2. Known immune deficiency (e.g. HIV, malignancy, solid-organ transplant recipients) or currently recieving immunosuppression therapy.3. Systemic antibiotics for any reason (treatment or prophylaxis) in the previous 14 days.4. Weight > 50kg.5. Known allergy to cefalexin or previous severe allergic reaction to any beta-lactam antibiotic** e.g. ampicillin, amoxicillin, cephalosporins, co-amoxiclav, penicillin.


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Birmingham Childrens Hospital
    Steelhouse Lane
    Birmingham
    B4 6NH
  • Chelsea and Westminster Hospital
    Chelsea and Westminster Hospital NHS Foundation Trust 369 Fulham Road
    London
    SW10 9NH
  • Royal Preston Hospital
    Sharoe Green Lane Fulwood
    Preston
    PR2 9HT
  • Leicester Royal Infirmary
    Infirmary Square
    Leicester
    LE1 5WW
  • St Georges Hospital
    Blackshaw Road Tooting
    London
    SW17 0QT
  • The Royal Belfast Hospital for Sick Children
    274 Grosvenor Road
    Belfast
    BT12 6BA
  • Bristol Royal Hospital for Children
    Paul O'Gorman Building Upper Maudlin Street St Michael's Hill
    Bristol
    BS2 8BJ
  • Sheffield Childrens Hospital
    Western Bank
    Sheffield
    S10 2TH
  • Royal Liverpool Childrens Hospital
    Alder Hey Hospital Eaton Road West Derby
    Liverpool
    L12 2AP
  • Children's Health Ireland at Crumlin
    Cooley Rd Crumlin
    Dublin
    D12 N512

Benefits:
Children who take shorter treatments of cefalexin in the study may have fewer antibiotic side effects, such as diarrhoea, allergic reactions and thrush. Shorter treatments of antibiotics also stop ‘bad bacteria’ from forming. ‘Bad bacteria’ can be difficult to treat as some antibiotics can’t kill them.
Taking part in the study will help children in the future as we will know the best number of days of cefalexin to give.
Cefalexin used in the trial will be a standard proprietary oral liquid suspension. After reconstitution, each bottle contains 100ml of suspension at a concentration of 250mg/5ml. CURLY will apply the British National Formulary for Children weight-based cefalexin dosing schedule, following the target dose of 12.5 mg/kg twice daily. To reduce the risk of dose calculation errors and ensure that the desired volume is easy to draw-up, all sites will prescribe using a prespecified weight-dose volume table.
Cefalexin has a well-established safety profile, and it will be used within its current marketing authorisation. Clinicians will see patients face-to-face prior to prescribing the medication and will describe common side-effects of cefalexin, and what should be done if they occur. This information is also included within the CURLY website (and PIS). The CURLY app will explicitly prompt for known clinical adverse effects of cefalexin, primarily diarrhoea, rashes, and candida infections and these will be recorded on the eCRF. Any side-effects will be dealt with as per standard clinical practice. Expedited events will be reported to BCTU by the site as defined in the trial protocol.
For CURLY, there are no drug interactions or contraindications of note for cefalexin, other than those mentioned in the licensing label. As stated in the exclusion criteria, any child with a known allergy to cefalexin or previous severe allergic reaction to any beta-lactam antibiotic will be excluded from participation in the trial.
In CURLY, normal pathways of care will be encouraged. However, there is a responsibility to balance this approach with the need to ensure the safety of all patients, particularly those treated for shorter durations than the current recommended practice.
Compared with standard clinical practice, additional measures for trial participants will be:
• The medicine tracker feature within the CURLY app will help parents/guardians to track medicine administration.
• Parents/guardians will be provided with a telephone contact number at their local site for any questions or concerns.
• A text/email alert will be sent to the parent/guardian on the final day of treatment, reminding them that the cefalexin is due to finish, but recommending medical review if their child’s symptoms are not resolving.
• A text/email “fit and well” check will be performed 48-72 hours after the end of treatment, asking the parent/guardian to report if their child has ongoing fever or other symptoms of concern and advising them to consider seeking medical advice for any ongoing issues. These concerns will be automatically flagged to the local trial team.
• Parents/guardians will have access to the CURLY trial website throughout the duration of the trial.
• If at any point the parent/guardian fails to respond to the text/email questionnaires, or if they do not attend the primary outcome visit, the local study team will attempt to telephone the parent/guardian to ensure that all is well with their child and, if necessary, to provide support and advice.
During PPI workshop discussions, parents and children/young people all felt that families would accept the (day 16) face-to-face follow-up as a positive opportunity for reassessment by a doctor. This would help reassure parents and children. The benefits of this reassurance were felt to outweigh any inconvenience of the appointment. Children and young people agreed that the final (day 30) follow-up assessment should not be done at the hospital. This was because most of the older participants would have recovered and returned to nursery or school.
A Trial Steering Committee (TSC), Trial Management Group (TMG) and Data Monitoring Committee (DMC) are in place for this trial. Regular meetings will occur as follows and email correspondence will be used for ad-hoc meetings/discussion and issues that require urgent advice or resolution:
(i) The DMC will meet before the start of patient recruitment, then at the end of the pilot phase to review the study data and advise on the continuation of the trial. The DMC will particularly consider safety, treatment side effects, presence of symptoms and report recommendations (if any) to the TSC.
(ii) The TSC will meet before the start of patient recruitment, then at least annually to provide advice to the TMG taking into consideration the DMC recommendation.
(iii) The TMG will meet every 4 weeks; this frequency will be adjusted according to need as the trial progresses.
No formal futility rules have been set to close the trial prematurely, however an internal pilot will be conducted over the first 6 months of recruitment to assess the feasibility of identifying eligible patients, to assess the acceptability of randomisation, and to determine if the pilot phase should continue to a full trial.

Dr Stuart Hartshorn
+44 121 3339527
stuart.hartshorn@nhs.net


Dr Study Team
+44 121 415 9125
curly@trials.bham.ac.uk



More information about this study, what is involved and how to take part can be found on the study website.


The study is sponsored by University of Birmingham and funded by National Institute for Health and Care Research.



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Read full details for Trial ID: ISRCTN65844003

Or CPMS 58938

Last updated 07 February 2025

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